Compliance Resources to Help you Stay Current

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OSHA’s New Laboratory Safety Guidance – Overview and Summary of Requirements

  • Industry: Laboratory Compliance

On October 13, 2011, OSHA announced the release of a new and revised Laboratory Safety Guidance document aimed at protecting lab workers from exposure to chemical, biological and physical hazards.

This article gives an overview of this new guidance document and its requirements.

Good Laboratory Practices - Why Focus on Laboratory Quality Systems?

  • Industry: Laboratory Compliance

Following good laboratory practices (GLPs) is necessary to ensure that quality is maintained and results are accurate. In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, gives practical tips on the following GLP areas:

  • General Laboratory Practices and Test Procedures
  • Laboratory Documentation
  • Laboratory Training and Personnel Certification

Test Method Validation – Special Focus: Cleaning Validation - What is the biggest challenge?

  • Industry: Laboratory Compliance

In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, discusses the best ways to conduct cleaning test method validation. Marcelle discusses the various steps involved and different regulatory recommendations for this essential process in the manufacture of drug products.

Ideas about Implementation of Microbial Environmental Monitoring Program for Non Sterile Forms

  • Industry: Laboratory Compliance

This article establishes a rationale to justify the level and extension of Environmental Monitoring to be applied at non-sterile pharma facilities based on the risk compound by  factors such as location and product susceptibility to microbial contamination.

The author, Marcelle Cortezia, has ten years of experience with major pharmaceutical companies and is at present a Quality Manager with Dentsply.

ISO/IEC 17025 – Applicability, Use and Summary of Requirements

  • Industry: Laboratory Compliance

The ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories - is an international standard that applies to laboratories. It specifies the general requirements for the competence required in a laboratory to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

This article describes the applicability and use of this standard and summarizes its requirements.

Sunrise Medical Laboratories, Inc received warning letter in violation to 21 CFR Part 1271

  • Industry: Laboratory Compliance

On Feb 23 2011 Sunrise Medical Laboratories, Inc a clinical and anatomical pathology laboratory received warning letter from FDA in relation to violation of not providing adequate protections against the risks of communicable disease transmission through the use of the HCT/Ps for which the company performs testing for relevant communicable diseases. The agency has also determined that there are reasonable grounds to believe this violative HCT/Ps pose a danger to health. Hence the agency has issued an order to Order to Cease Manufacturing effective with immediate notice. This Order to Cease Manufacturing relates to conduct occurring on or after May 25, 2005, the effective date of the applicable regulations. FDA retains authority to pursue other actions and remedies.

The warning letter states “Because of your failure to provide adequate protections against the risks of communicable disease transmission, pursuant to 21 CFR 1271.440(a)(3), Sunrise Medical Laboratories must immediately cease all manufacturing of HCT/Ps until compliance with the regulations in 21 CFR 1271 has been achieved and you have been provided written authorization from FDA to resume operations. Under 21 CFR 1271.3(e) manufacture means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any HCT/P, and the screening or testing of the HCT/P donor.

Additionally, this is to advise you that FDA will notify, by copy of this Order, the client reproductive facilities for whom you performed donor testing since January 2008.”

FDA’s inspection and record review noted significant noncompliance with the federal regulations including, but not limited to, the following:

A. Donor Testing

  1. Failure to test using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer’s instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or disease [21 CFR 1271.80(c)]
  2. The manufacturer’s instructions for the hepatitis B core (HBc) assay state the absorbance value for the substrate blank must be greater than or equal to ---(b)(4)--- and less than or equal to ---(b)(4)--. The instructions further state that these criteria must be met in order for a plate (test run) to be considered valid. For 76 assays performed between January 2008 and October 2010, the blank absorbance value was greater than -(b)(4)-. The assays were not considered invalid and the results were reported to clients despite being obtained from an invalid test run.
  3. The manufacturers of the test kits used for HIV-1/2, HBc, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV), require the use of a multichannel aspirator-washer capable of dispensing and aspirating 300µL to 800µL of wash solution per microplate well. In addition, the manufacturer’s instructions caution that strict adherence to the specified wash procedure is critical to ensure optimum assay performance. The instructions provide very specific steps to follow for washing the microplates. However, your firm’s procedure involves using a hand-held irrigation bottle to wash the wells, then inverting the microplates over a laboratory waste container to discard the wash solution. This method has been standard practice at Sunrise Medical Laboratories since January 2008, and was observed by the investigator during the inspection and documented in an affidavit signed by Mr. Paul Doherty, Laboratory Manager, on November 18, 2010.
  4. The incubation and washing steps for the HBc, HBsAg, HCV, and HIV-1/2 assays are not always performed for the required time specified in the manufacturer’s instructions. During the inspection, on October 28, 2010, the investigator observed that incubation times for specific steps in the assays were not documented or verified.
  5. The manufacturer’s instructions for the HBc assay require re-testing of donor specimens with an absorbance reading of less than -(b)(4)-. On 6/17/10, the absorbance reading for donor ----(b)(6)--- was -0.034. The donor specimen was not re-tested and the result of testing of this HCT/P donor was reported as negative.


Failure to maintain records concurrently with the performance of each step required in subpart D and subpart C of Part 1271. 21 CFR 1271.270(a) states that any requirement in Part 1271 that an action be documented involves the creation of a record, which is subject to the requirements of this section. In addition, this section requires that all records must be accurate, indelible, and legible and that the records must identify the person performing the work and the dates of the various entries, and must be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular HCT/P involved. For example:

  1. From January 2008 to October 2010, you did not document incubation temperatures and times; solution preparation and usage times; and stop solution addition times for HBc, HBsAg, HCV, syphilis, and HIV-1/2 assays.
  2. The identification of the individual performing HBc, HBsAg, HIV-1/2, and syphilis assays was not documented on 180 out of -(b)(4)- worksheets/plate reader printouts.
  3. Donor specimen numbers were not documented on 40 out of -(b)(4)- data sheets/plate reader printouts for HBc assays performed in 2008.
  4. The calculation of the average value of the negative controls was not documented for three HCV assays and four HBsAg assays performed in 2008 and 2009

FDA further says that the testing was not performed in accordance with manufacturer’s instructions. Specifically: improper washing of microplates; failure to monitor the time and temperature of each step performed in testing; failure to invalidate test runs which did not meet manufacturer’s acceptance criteria and misinterpretation of test results based on use of an incorrect cutoff value.

FDA instructs the company to inform its’ client reproductive facilities and FDA of each donor test result that was affected by non-compliance with the manufacturer’s instructions in order that the client can make an informed decision regarding the status of the donor and /or any affected HCT/Ps that may remain in their inventory.


For more details of this warning letter

Rapid Microbiological Methods - improve the detection, quantification and identification of mic ....

  • Industry: Laboratory Compliance

Rapid Microbiological Methods (RMMs) are methods designed to provide performance equivalent to the sterility testing methods described in 21 CFR 610.12, while providing results in significantly less time. In general, RMMs are based on technologies which can be growth-based, viability-based, or surrogate-based cellular markers for a microorganism (i.e., nucleic acid-based, fatty acid-based). RMMs are frequently automated, and many have been utilized in clinical laboratories to detect viable microorganisms in patient specimens. These methods reportedly possess increased sensitivity in detecting changes in the sample matrix (e.g., by-products of microbial metabolism), under conditions that favor the growth of microorganisms.

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